and according to specifications. Perform operational qualification (OQ) and performance qualification (PQ) activities to verify...
projects, process development (IQ, OQ, PQ), material evaluation, risk management, and verification/validation with cross...
Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation (PV). Collaborate...
experience. Orthopaedic experience preferred. Expertise in FMEAs and IQ, OQ, PQ validation. Strong understanding of regulatory...
projects. Drive process improvements, change control, and validation activities (TMVs, IQ/OQ/PQ). Direct preventive...
quality. Ensure equipment qualification, process validation (IQ/OQ/PQ) and process control plans are implemented...
. Perform and analyze IQ, OQ, PQ qualifications and other validation activities. Collaborate with cross-functional teams... of experience in process validation (medical device experience required;not pharma). Hands-on experience with IQ, OQ, PQ and FMEAs...
and preventive actions (CAPA) and writing validation reports (IQ/OQ/PQ). Solid knowledge of GD&T, PFMEA and Control Plans...
acquisition, installation and qualification of production equipment and tooling, including writing the IQ, OQ, PQ documentation...
, PQ) protocols, engineering studies and final reports that comply with corporate and regulatory requirements. Coordinate...